E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To replicate previous findings showing that oral naltrexone prevents relapse to amphetamine addiction and extend these results using a 6 month course of extended release naltrexone (Vivitrol®) or placebo in treatment seeking amphetamine addicted patients in Iceland. |
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E.2.2 | Secondary objectives of the trial |
To compare the relative efficacy of extended release naltrexone (Vivitrol®) to (Vivitrol®) placebo on 1) reducing self reported amphetamine and other drug use, HIV risk, treatment dropout, craving for amphetamines, crimiminal activity, and symptoms of depression and 2) improving quality of life. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria 1) Aged 18 or above. 2) Primary diagnosis of current amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month. 3) Patient and clinician identify amphetamine dependence as the main problem. 4) Successfully complete 7-10 day assessment and study baseline measures at Vogur. 5) Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines [unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo. 6) Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly. 7) Successfully complete 7-10 day assessment and study baseline measures at Vogur. 8) Written informed consent.
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1) Any liver test >5 times the top limit of normal. 2) Physiologically dependent on opioids or other substances (nicotine excepted) at time of study inclusion. 3) Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge. 4) Schizophrenia, Bipolar I or other non-substance related psychotic disorder. 5) Severely depressed, suicidal or homicidal. 6) Dementia. 7) Inability to understand the informed consent. 8) Planning to move from the Reykjavík area or enter jail within next 6 months. 9) Medical problems that need immediate attention or that, in the opinion of the investigator, will interfere with ability to participate. 10) Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure. 11) Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG), carboxymethylcellulose, or any other component of the diluents. 12) Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control. 13) A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment. 14) Use of an investigational agent in the past 30 days.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of amphetamine negative urines during weeks 1-24 of outpatient treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |